Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Inclusion Criteria

• DCIS or Stage I-III primary invasive carcinoma of the breast
• Primary surgical treatment is lumpectomy + SLNB or ALND --or-- mastectomy + ALND
• Signed written informed consent
• At least 18 years of age
• ECOG performance status 0 to 2
• Life expectancy of at least 6 months
• Total bilirubin ≤ 2 mg/dL
• AST/SGOT and ALT/SGPT ≤ 2.5 X ULN
• Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
• LVEF within normal limits if patient received prior anthracycline therapy [Period 1].

Exclusion Criteria

• Recurrent ipsilateral breast cancer
• Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
• Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
• Open surgery in ipsilateral breast within 1 year.
• Prior malignancy, other than breast cancer, active within the last 6 months
• Prior radiation therapy to the chest [Period 2]
• Radiation therapy to ipsilateral breast [Period 1]
• Abnormal cardiac rhythm not controlled with medication; Hx of stroke within 1 year; Hx of coronary events and/or heart failure within 1 year.
• Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
• Hx of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids.
• Hx of drug-induced acute tubular necrosis.
• Chronic renal failure or current evidence of moderate to severe renal impairment.
• Current diagnosis of any other active or clinically significant nonbreast cancer
• Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously.
• Pregnant or breast feeding or plans to become pregnant within 6 months of AVB-620 administration.
• Unresolved acute toxicity from prior anticancer therapy